The Effect of Preoperative Oral Prednisone on the Operative Field During Nasal Polypectomy.
This study aims to determine if a short course of oral prednisone helps to improve the operative field and ease of surgery by minimizing bleeding during nasal polypectomy surgery.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||The Effect of Preoperative Oral Prednisone on the Operative Field During Nasal Polypectomy.|
- Intraoperative blood loss. Wormald Surgical Field Grading Scale [ Time Frame: Intraoperative ] [ Designated as safety issue: No ]This is an 11-point validated scale designed to provide a standardized method of documenting bleeding in endoscopic sinus surgery [Athanasiadis et al., 2007]. In addition blood loss during the surgery will be calculated from the suction canisters after accounting for the amount of irrigation used.
- Visibility and easy of surgery [ Time Frame: Immediate Postoperative period ] [ Designated as safety issue: No ]The surgeon will assess visibility and easy of surgery during the surgery and the technical difficulty of the surgery using two visual analogue scale questions.
- Endoscopic assessment [ Time Frame: 4 weeks, 3 months, 6 months ] [ Designated as safety issue: No ]The Peri-Operative Sinus Endoscopy (POSE) scoring system (total score) will be used to assess the condition of the patients' sinus cavities and the Lindholdt scale will be used to provide objective measures of polyp recurrence size based on the percent obstruction of the nasal cavity and obstruction based on anatomic location.
- Quality of life survey (SNOT22) [ Time Frame: 2 weeks, 4 weeks, 3 months, 6 months post-op ] [ Designated as safety issue: No ]The Sino-nasal Outcome Test - 22 (SNOT-22) will be used as the main instrument to assess patients' disease specific symptoms. The total score from the SNOT-22 at 3 months follow-up will be the main outcome. The profile of symptom scores over the full follow-up period will be a secondary outcome.
|Study Start Date:||November 2010|
|Study Completion Date:||June 2013|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Experimental: Prednisone group
Prednisone 50 mg daily for 10 days immediately pre-op
Drug: Oral Prednisone
Prednisone 50 mg once daily for 10 days pre-op
Placebo Comparator: Placebo group
Placebo pill for 10 days immediately pre-operative
Drug: Placebo comparator
Placebo pill identical to Prednisone 10 days once daily pre-op
Other Name: sugar pill
This study will be conducted as a double blinded randomized control trial and aims to recruit about 34 patients (17 patients per arm). Patients will be randomized to receive either prednisone 50 mg po x10 days or an identical looking placebo x10 days. Photographs of the polyps will be taken prior to the intervention, on the day of surgery and in the follow-up visit. Symptom survey (SNOT22) will also be administered at these same time points. Blood loss will be determined volumetrically from the suction canister and by using the Wormald Surgical field grading scale. Surgeons will also complete a survey postoperatively evaluating visibility, difficulty and ease of surgery. At 2 weeks, 1 month, 3 months and 6 months, patients will again fill out the Sino-nasal Outcome Test - 22 (SNOT-22) and the surgeon will do an endoscopic assessment by using the Peri-Operative Sinus Endoscopy (POSE) scoring system .
Please refer to this study by its ClinicalTrials.gov identifier: NCT00440219
|Mount Sinai Hospital, University of Toronto|
|Toronto, Ontario, Canada, M5G 1X5|
|St. Joseph's Health Centre|
|Toronto, Ontario, Canada, M6R 1B5|
|Principal Investigator:||Ian Witterick, MD FRCSC||University of Toronto Department of Otolaryngology-Head and Neck Surgery|
|Study Director:||Randy M Leung, BSc MD||University of Toronto Department of Otolaryngology-Head and Neck Surgery|